NCT01876680

Brief Summary

The purpose of this study is to investigate the effects of specific neck/shoulder muscle exercises on pain, function, biochemistry and psychological factors in women suffering chronic neck/shoulder pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2011

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

September 5, 2011

Last Update Submit

June 10, 2013

Conditions

Keywords

chronicneckshoulderexercise

Outcome Measures

Primary Outcomes (2)

  • Pain

    Methods of measurement: Surveys, physical tests, microdialysis.

    Before training, 4-6 months and after one year of training.

  • Function

    Methods of measurement: Surveys, physical tests, microdialysis.

    Before training, 4-6 months and after one year of training.

Secondary Outcomes (3)

  • Muscle biochemistry

    Before training, 4-6 months follow-up and 12 months follow-up

  • Psychological factors

    Before training, 4-6 months follow-up and 12 months follow-up

  • Pain sensitivity

    Before training, 4-6 months follow-up and 12 months follow-up

Study Arms (2)

Group 1: Stretching and aerobic exercise

EXPERIMENTAL

Group 1 undertook a stretching programme for neck/shoulder muscles three times weekly and performed aerobic exercise för 30 minutes three times weekly.

Other: Stretching and aerobic exercise

Group 2: Strength training

EXPERIMENTAL

Group 2 undertook a stretching programme for neck/shoulder muscles three times weekly, performed aerobic exercise three times weekly and performed weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly.

Other: Strength training

Interventions

Stretching programme for neck/shoulder muscles three times weekly and aerobic exercise för 30 minutes three times weekly. Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year.

Group 1: Stretching and aerobic exercise

Stretching programme for neck/shoulder muscles three times weekly, aerobic exercise för 30 minutes three times weekly and weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly. Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year.

Group 2: Strength training

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • long term neck/shoulder muscle pain
  • willing to exercise

You may not qualify if:

  • widespread pain
  • pregnancy
  • major trauma in medical history
  • tendonitis in upper extremities
  • neurological causes of the pain
  • inflammatory and hormonal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences, Linköping University

Linköping, Östergötland County, SE 581 85, Sweden

Location

Related Publications (2)

  • Ghafouri N, Ghafouri B, Fowler CJ, Larsson B, Turkina MV, Karlsson L, Gerdle B. Effects of two different specific neck exercise interventions on palmitoylethanolamide and stearoylethanolamide concentrations in the interstitium of the trapezius muscle in women with chronic neck shoulder pain. Pain Med. 2014 Aug;15(8):1379-89. doi: 10.1111/pme.12486. Epub 2014 Jul 4.

  • Karlsson L, Takala EP, Gerdle B, Larsson B. Evaluation of pain and function after two home exercise programs in a clinical trial on women with chronic neck pain - with special emphasises on completers and responders. BMC Musculoskelet Disord. 2014 Jan 8;15:6. doi: 10.1186/1471-2474-15-6.

Related Links

MeSH Terms

Conditions

Neck PainBronchiolitis Obliterans SyndromeMotor Activity

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Britt Larsson, Assoc Prof

    rehabilitation medicine, Faculty of Health Sciences, Linköping University, SE 581 85, Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor MD, Rehabilitation Medicine

Study Record Dates

First Submitted

September 5, 2011

First Posted

June 12, 2013

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations